DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of invention I in the reply filed on 7/8/25 is acknowledged.
Claims 8-17 and 19-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/8/25.
Claims 1-7 are examined on the merits.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(Prior Rejection Maintained) Claim(s) 1, 4, 6 and 7 are rejected under 35 U.S.C. 102a1 as being anticipated by Anderson et al. (US PGPub 2019/0225968).
The claimed invention is drawn to a composition comprising a class B CpG conjugated to a nanoparticle and a class C CpG conjugated to a nanoparticle. The composition is also part of a pharmaceutical composition with a pharmaceutically acceptable carrier, excipient or diluent and it is in injectable formulation.
Anderson et al. compositions comprising CpG sequences formed into spherical nucleic acid (SNA) structures. [see paragraphs 27-29] The CpG can be from class A, B or C. [see paragraph 33] in order to form the spherical nucleic acids, Anderson et al. teaches that gold nanoparticles can be used as the core of the SNA. [see paragraph 51] Anderson et al. also teach that oligo ethylene glycol and poly T sequences can be part of the oligonucleotide structure. [see paragraph 115] Anderson et al. also teach that their SNA can be delivered via injection. [see paragraph 88] Therefore, Anderson et al. anticipate the instant invention.
Response to arguments:
Applicant presents the following arguments in traversal of the rejection:
Anderson et al. fails to teach a composition comprising two different types of CpG-conjugated nanoparticles, one with Class B CpGs and the other with Class C CpGs.
In response, Anderson et al. teach spherical nucleic acids that comprise class A, B and C CpGs [see paragraph 33] and the formation of gold nanoparticles that comprise these CpGs [see paragraph 51] Anderson et al. also teach that mixtures class A, B and C CpGs are also contemplated [see paragraph 14] and that lipid nanoparticles comprising a mixture of classes A, B and C are contemplated [see claims 18, 19 and 32, paragraphs 14 and 33]. These mixtures would include more tha one nanoparticle possessing Class A, B and C CpGs, which would include the claimed composition. Therefore, Anderson et al. anticipate the instant invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
(Prior Rejection Maintained) Claim(s) 2, 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. as applied to claims 1, 4, 6 and 7 above, and further in view of Lin et al. (PLoS ONE, 2013, Vol. 8, No. 5).
The claimed composition also comprises CpG is conjugated to different nanoparticles and each CpG has a spacer between the CpG and the nanoparticle. Examples of spacers are a polyT sequence and oligo ethylene glycol or both are used.
The teachings of Anderson et al. are summarized above. However, they do not teach the specific use of polyT or oligo ethylene glycol as spacers between the CpG and the nanoparticle.
Lin et al. teach the development gold nanoparticles which deliver CpG in order to stimulate an immune response. Examples of the gold nanoparticles + CpG are shown in figure 1:
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Therefore, Lin et al. teach the use of polyT linkers with or without oligoethylene glycol in order to conjugate a CpG to a gold nanoparticle.
It would have been obvious to one of ordinary skill in the art to modify the compositions taught by Anderson et al. in order to utilize polyT sequences and/or oligo ethylene glycol to link the class B and C CpGs to gold nanoparticles. One would have been motivated to do so, given the suggestion by Anderson et al. that CpGs of class A, B and/or C be immobilized on nanoparticles, including gold nanoparticles. There would have been a reasonable expectation of success, given the knowledge that polyT and oligo ethylene glycol can be used to immobilize CpG to gold nanoparticles, as taught by Lin et al. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to arguments:
Applicant’s arguments have been considered, but they are not persuasive:
The deficiencies related to the teachings of Anderson et al. are addressed in the response to the 35 USC 102a1 rejection above. Applicants have not established why one of ordinary skill in the art would not be motivated by the teachings of Lin et al. to use of polyT or oligo ethylene glycol as spacers between the CpG and the nanoparticles of Anderson et al. Therefore, this rejection has been maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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